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Completed

NCT Number: NCT00536653

Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer

The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.

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Key information

About this study

Androgen ablation is the mainstay of treatment for advanced prostate cancer. However,luteinizing hormone-releasing (LHRH) agonists are associated with accelerated bone loss, osteoporosis and fractures. An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. Our aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation. All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry. Osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. Osteopenic and normal BMD patients will be commenced on LHRH agonists. All osteopenic and osteoporotic patients will be given calcium and vitamin D supplementation.Patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and PSA levels. Any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of LHRH and bicalutamide or additional oestrogen therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated

Exclusion criteria

  • Previous systemic therapy for prostate cancer
  • Patients with any illness or medication that would affect bone and mineral metabolism
  • Severe hepatic or renal insufficiency

Treatment and study plan

Bicalutamide and Calcium/ Vitamin D supplementation

Drug

Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily

LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation

Drug

3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily

LHRH agonists (Goserelin acetate)

Drug

3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)

Primary outcomes

  1. Peripheral Forearm bone mineral density

    Time frame: Over 7 years

Secondary outcomes

  1. Fractures of the thoracolumbar spine

    Time frame: Over 7 years

Sponsors and collaborators

Lead sponsor

Wirral University Teaching Hospital NHS Trust

Other

Registry information

Official study title

Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values

Important dates

Study start
1999
Study completion
2007
First posted
Sep 28, 2007
Registry last updated
Sep 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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